118 STAT. 891 PUBLIC LAW 108–282—AUG. 2, 2004 Public Law 108–282 108th Congress An Act To amend the Federal Food, Drug, and Cosmetic Act with regard to new animal drugs, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, TITLE I—MINOR USE AND MINOR SPECIES HEALTH SECTION 101. SHORT TITLE. This title may be cited as the ‘‘Minor Use and Minor Species Animal Health Act of 2004’’. SEC. 102. MINOR USE AND MINOR SPECIES ANIMAL HEALTH. (a) FINDINGS.—Congress makes the following findings: (1) There is a severe shortage of approved new animal drugs for use in minor species. (2) There is a severe shortage of approved new animal drugs for treating animal diseases and conditions that occur infrequently or in limited geographic areas. (3) Because of the small market shares, low profit margins involved, and capital investment required, it is generally not economically feasible for new animal drug applicants to pursue approvals for these species, diseases, and conditions. (4) Because the populations for which such new animal drugs are intended may be small and conditions of animal management may vary widely, it is often difficult to design and conduct studies to establish drug safety and effectiveness under traditional new animal drug approval processes. (5) It is in the public interest and in the interest of animal welfare to provide for special procedures to allow the lawful use and marketing of certain new animal drugs for minor species and minor uses that take into account these special circumstances and that ensure that such drugs do not endanger animal or public health. (6) Exclusive marketing rights for clinical testing expenses have helped encourage the development of ‘‘orphan’’ drugs for human use, and comparable incentives should encourage the development of new animal drugs for minor species and minor uses. (b) AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.— 21 USC 360ccc note. 21 USC 301 note. Minor Use and Minor Species Animal Health Act of 2004. Aug. 2, 2004 [S. 741]
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